Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies

Phase 2

• Conditions: Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Multiple Myeloma; Non Hodgkin Lymphoma
• Interventions: Drug: Thiotepa

• Registration Number: NCT02507479
• Lead Sponsor: Sheba Medical Center

Brief Summary

The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-14
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Study Start: 2015-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20
• Primary Completion: 2017-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Age less than physiologic 68 years.

2. Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:

   1. MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
   2. Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
   3. Follicular lymphoma; failure of at least one prior regimen
   4. CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality

3. Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB) typing. The goal is to transplant > 3 x 106 CD34+ cells per kg body weight of the recipient

4. Patients must sign written informed consent.

5. Adequate birth control in fertile patients.

Exclusion Criteria

1. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
2. Creatinine > 2.0 mg/dl
3. ECOG-Performance status > 2
4. Uncontrolled infection
5. Pregnancy or lactation
6. Abnormal lung diffusion capacity (DLCO < 40% predicted)
7. Severe cardiovascular disease
8. CNS disease involvement
9. Pleural effusion or ascites > 1 liter
10. Known hypersensitivity to Fludarabine or treosulfan
11. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
thiotepa	Thiotepa	Thiotepa 5-10 mg/kg/d x 2 days

Primary Outcome Measures

Name	Time	Method
disease-free survival	2 years after transplantation	The percentage of patients alive without disease recurrence 2 years after transplant

Secondary Outcome Measures

Name	Time	Method
treatment-related mortality	2 years after transplantation	The percentage of patients who die of complications related to the transplant
graft versus host disease	1 year after transplantation	The percentage of patients experiencing graft-versus-host disease after transplant
relapse	2 years after transplantation	The percentage of patients experiencing disease recurrence after transplant

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Tel-Hashomer, Israel